QARA

The Clinical Subject Matter Expert (SME) will be responsible for the clinical support of device risk management activities. SME will have the following responsibilities: Review and approval of the clinical workflow definitions for the subject devices Identification of the clinical hazards and associated harms for the subject devices Estimation of the severity and probability of occurrence for the clinically related hazardous situation Development of the clinical benefit statements for the subject device Key skills and experience: A degree in a clinical related field (RN, MD) 10 years of clinical experience Understanding of device development in an FDA regulated environment Experience with ISO 14971 risk management activities Experience with the post market medical device support (complaint or risk analysis) Skill and Experience Details: Minimum Experience Required: Mandatory Skills: Medical Data Acquisition and Storage Consulting Desirable Skills: Clinical Systems, Medical Devices - QARA Language Skills: English Language Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Deegit Inc